Denosumab approved to prevent cancer-related bone injury in metastatic cancer

The FDA announced that denosumab has been approved as a preventive treatment for skeletal-related events in patients with cancer that has metastasized into the bone.

The indication includes prevention of bone fractures from cancer and bone pain requiring radiation. Denosumab (Xgeva, Amgen), a fully human antibody against the RANK ligand, is not approved for patients with multiple myeloma or other cancers of the blood.

The FDA based the ruling on three randomized, double blind clinical studies involving 5,723 patients that compared denosumab with zoledronic acid (Zometa, Novartis). The two drugs were compared in patients with breast cancer, prostate cancer and a variety of other cancers in the studies.

In trial results presented at this year’s ASCO Annual Meeting, men with castration-resistant metastatic prostate cancer were randomly assigned to 120 mg denosumab (n=950) or zoledronic acid (n=951).

Median time to first serious adverse event was 20.7 months for denosumab vs. 17.1 months for zoledronic acid (HR=0.82; 95% CI, 0.71-0.95). Denosumab also delayed the time to first and subsequent skeletal-related events (HR=0.82; 95% CI, 0.71-0.94).

In patients with breast cancer, median time to first skeletal-related event was 26 months with zoledronic acid and has not yet been reached with denosumab.

The most serious adverse events associated with denosumab are hypocalcemia and osteonecrosis of the jaw.

Denosumab was first approved in June, under the trade name Prolia, to treat postmenopausal women with osteoporosis at high risk for bone fractures.

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